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The FDA cited five dietary supplement manufacturers for marketing and distributing ASN Canthaxanthin and Universal Canthaxanthin tablets as anticancer agents without approval from the agency.
Sen. Byron Dorgan (D-N.D.) said he has enough votes in both houses of Congress to pass the legislation that would allow Americans to import prescription drugs from as many as 30 countries into the U.S.
An FDA analysis of purported generic versions of three popular Rx drugs purchased from a website advertised as Canadian revealed the products to be potentially dangerous, according to the agency.
The primary sponsor of a bill that would allow Americans to import prescription drugs from as many as 30 countries into the U.S. said he has enough votes in both houses of Congress to pass the legislation.
A joint FDA advisory committee has recommended the agency not approve Allergan’s oral retinoid treatment for psoriasis, saying that although the treatment demonstrated modest efficacy in pivotal trials, the accompanying risk management program is inadequate.
HHS is rebutting Rep. Henry Waxman’s charge that the department’s plan for speeding up the approval process for combination AIDS drug therapies will actually delay the products’ availability.
A federal court in the District of Columbia has refused King Pharmaceuticals’ request to revoke FDA approval of supplemental new drug applications (sNDAs) that propose to establish bioequivalence between King’s thyroid product Levoxyl and two other products: Jerome Stevens’ Unithroid and Mova Pharmaceutical’s Levo-T.
A pending trade agreement with Australia could block the importation of prescription drugs from Australia into the U.S. and set a precedent for blocking drug importation from other countries as part of future free trade agreements (FTAs), a member of Congress has warned.
Drugmakers’ wholesale prices for nearly 200 brand Rx drugs most commonly used by seniors increased far faster than the rate of inflation for the first three months of 2004, according to a study released yesterday by the AARP.
Final action on a rule governing labeling for human prescription drugs is set for October, according to the FDA’s Semiannual Regulatory Agenda, published in the Federal Register earlier this week.